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NCT01546038 · OUTCOME

Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit - Cycle 1/Day 1

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2020-03-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
pg/mL
Interval / dispersion
Full Range
Time frame
Cycle 1/Day 1, 1 Hour Post-dose

What was measured

Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.

Analysis population: PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.

Groups in this outcome

Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)

AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).

Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)

AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)6
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)12

Reported measurements

Factor VII:activated blood coagulation factor VII
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)311500Not reported48000661000Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)234500Not reported147000676000Not reported
IL-6 (Interleukin-6)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)0.00Not reported0.003.50Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)6.80Not reported0.0062.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48000
        upper Limit
        661000
        value
        311500
      2. group Id
        OG001
        lower Limit
        147000
        upper Limit
        676000
        value
        234500
    title
    Factor VII:activated blood coagulation factor VII
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        3.50
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        62.00
        value
        6.80
    title
    IL-6 (Interleukin-6)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.
dispersion Type
Full Range
groups
  1. description
    AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
    id
    OG000
    title
    Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)
  2. description
    AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
    id
    OG001
    title
    Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)
param Type
MEDIAN
population Description
PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.
reporting Status
POSTED
time Frame
Cycle 1/Day 1, 1 Hour Post-dose
title
Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit - Cycle 1/Day 1
type
SECONDARY
unit Of Measure
pg/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice